Gastrointestinal endoscopy with attachable intestine pleating structures

ABSTRACT

Disclosed herein are intestine pleating attachable structures for use with endoscopes and methods for using said structures. The intestine pleating attachable structures may act in conjunction with a gastrointestinal endoscope and, optionally, a balloon to improve visualization during endoscopic procedures. The intestine pleating attachable structures are coupled to the endoscope shaft, and include at least one flexible appendage to enhance contact between the structure and the intestinal wall. When the endoscope is retracted, the flexible appendage assists in moving the intestinal wall relative to the imaging system. This movement causes the intestine to pleat. Pleating reduces looping, improves efficiency, and results in a less painful endoscopic procedure for the patient. The attachable structures may be used in conjunction with a dome-shaped balloon that is inflated at the distal, imaging end of the endoscope. The balloon is transparent, such that the intestinal wall may still be visualized through the balloon while intestinal matter is prevented from obscuring the image.

RELATED APPLICATIONS

This application is a national stage application filed under 35 U.S.C. §371of PCT/US2015/016901, filed Feb. 20, 2015, which claims the benefitof and priority to U.S. Provisional Application 61/966,403, filed Feb.24, 2014, the disclosures of which are expressly incorporated herein byreference in their entireties.

TECHNICAL FIELD

The present apparatus embodied relates, in general, to medical devicesand in particular, to gastrointestinal endoscopy with attachableintestine pleating structures.

BACKGROUND

Endoscopes are welt-known in the art and are flexible devices that areinserted into a natural body orifice such as the mouth or anus toprovide visual and surgical access to portions of the upper and lowergastrointestinal (GI) tract. Endoscope accessible portions of the lowerGI tract extend from the anus to the small intestine, and during thisjourney, the flexible endoscope must traverse a torturous convolutedpath through the anus, the rectum, and through the large intestine tothe ileocecal opening of the small intestine. The torturous pathincludes an “S” shaped passage through the rectosigmoid junction and thesigmoid colon, and around several larger than right angled bends of thesplenic flexure and hepatic flexure. Additionally, in small bowelenteroscopy, an endoscope must traverse a large torturous convolutedpath having multiple “S” shaped passages.

Before insertion of the endoscope, the patient is given drugs to purgefecal matter from the lower GI tract. Once emptied, the tubular walls ofthe large intestine can flatten or collapse together into a flattenedtubular configuration. The collapsed intestines may inhibit passage ofthe flat face of the distal end of the endoscope, and the collapsedtissue can inhibit visualization by pressing against or near to a cameramounted within the flat face. To enhance the passage of the endoscopethrough the collapsed lower GI tract and to improve visualization,insufflation gas is routinely pumped into the patient's tower GI tractto expand and distend the collapsed tubular tissues. The expanded wallsmay improve visualization and reduce tissue contact with the flat faceof the endoscope as it is pushed farther and farther into theinsufflated lower GI tract. The distal portion of the endoscope issteerable, and the insufflated tissue can provide room for the surgeonto visually steer the endoscope through the path ahead.

The administration of insufflation gas to the lower GI tract can induceabdominal discomfort, and this has led to the common practice ofanesthetizing the patient during the procedure. Additionally,insufflation gas may cause lengthening of anatomy and spontaneousperforation. Post-surgical recovery times are provided to allow thepatient to purge insufflation gas and to awaken from the anesthesia. CO2is commonly used for insufflation as it is more readily absorbed throughthe patient's intestinal wall to reduce the post-operative recoverytime. CO2 gas control systems, CO2 tanks, and CO2 gas heaters must bepurchased and maintained in order to provide CO2 as an insufflation gas.

In general, a complete colonoscopy requires the physician to advance thecolonoscope into the colon, negotiate the sigmoid colon, and left andright colic flexures up to the cecum. Advancement of the endoscope isgenerally accomplished by manipulation of a steerable tip of theendoscope, which is controlled at the proximal end of the device by thephysician, in addition to torquing and pushing the endoscope forward orpulling it backward.

Problems regularly occur, however, when negotiating the endoscopethrough the bends of the colon, such as at the sigmoid and left andright colic flexures. These problems arise because the colon is soft andhas unpredictable fixation points to the viscera of the abdomen, and itis easily distensible. Consequently, after the steerable tip of theendoscope is deflected to enter a new region of the colon, the principaldirection of the force applied by the physician urging the end of thedevice into the patient's colon is not in the direction of the steerabletip. Instead, the force is directed along the axis of the endoscope andtowards the preceding bend(s), and causes yielding or displacement ofthe colon wall. This problem, also known as looping, causes the colon totake a non-native shape.

The loads imposed by the endoscope on the colon wall can have a myriadof possible effects, ranging from patient discomfort to spasticcramp-like contractions of the colon and even possible perforation ordissection of the colon. Consequently, the endoscope cannot be advancedas far as the cecum in a significant number of cases.

SUMMARY

During an endoscopic procedure, removal of an intestinal loop istypically accomplished by retracting the endoscope, then pushing forwardagain. This pushing and pulling pleats the intestine, creating foldsbehind the tip of the endoscope and flattening the wall in front of thetip. This flattening has the additional benefit of improvingvisualization of the adjacent intestinal wall. Disclosed herein areintestine pleating attachable structures for use with gastrointestinalendoscopes and methods for using said structures. As used herein, theterm “endoscope” is defined as a gastrointestinal endoscope.

The intestine pleating structures act in conjunction with an endoscopeand, optionally, a balloon, to improve visualization during endoscopicprocedures. During such a procedure, the intestinal pleating structuresare coupled to the endoscope shaft. The attachable structures mayinclude at least one flexible appendage to enhance contact between thestructure and the intestinal wall. When the endoscope is retracted, theflexible appendage assists in moving the intestinal wall relative to theimaging system. This movement reduces looping, improves efficiency, andresults in a less painful endoscopic procedure for the patient. Contactbetween the attachable structure and the intestinal wall is enhancedwhen the patient is not insufflated during the procedure.

The intestine pleating attachable structures include a body having aninner surface and an outer surface. The inner surface of the bodydefines a passageway for passage of an endoscope. The passageway of thebody has a proximal opening, a distal opening, and a centrallongitudinal axis extending through the passage. One or more flexibleappendages may extend from the outer surface of the body. The appendagesare biased toward the proximal opening of the body in a first positionat a first acute angle relative to the longitudinal axis of the body.The first acute angle is less than 50 degrees. For example, theappendages may be biased toward the proximal opening of the body at 35degrees in the first position.

The appendages are movable to a second position, in which the appendagetips point away from the proximal opening at a second acute anglerelative to the longitudinal axis. The greatest width of the attachablestructure, measured perpendicular to the longitudinal axis and extendingfrom a first appendage tip on one side of the longitudinal axis to asecond appendage tip on the other side of the longitudinal axis, is upto and including 33 millimeters.

In some embodiments, the body is a substantially continuous piece ofmaterial. The flexible appendages may be continuous with the flexiblebody. For example, the flexible appendages and the flexible body may bea continuous piece of the same material. In other embodiments, the bodyof the attachable structure is relatively less flexible than theflexible appendages. Thermoplastic elastomers may be used to form theattachable structures. In other embodiments, the structures may beformed of silicone.

The attachable structure has a length measured parallel to alongitudinal axis of the body. In some embodiments, the length isbetween 1-20 millimeters. Some embodiments of the body opening haveradii between 2-8 millimeters. Some embodiments of the body opening havea cross-sectional area between 12-201 mm².

The flexible appendages of the attachable structures have lengthsbetween 1-5 millimeters from an outer surface. The appendages may bealigned to each other with respect to their position along the body ofthe attachable structure, forming at least one row of flexibleappendages. In some embodiments, a row may comprise up to twentyappendages. In other embodiments, a row may comprise more than twentyappendages. Some attachable structures may have multiple rows offlexible appendages. The lengths of the flexible appendages, as measuredextending outwardly from the body of the attachable structure, may varyfrom row to row. For example, the flexible appendages of a first row maybe shorter than the lengths of the appendages on a proximally spacedrow. Alternatively, the lengths of the flexible appendages may be thesame regardless of the row.

The flexible appendages of the attachable structures include baseportions adjacent the flexible body and outer portions spaced outwardlyfrom the base portions. The outer portions of the appendages culminatein appendage tips. The flexible appendages may also include top facesthat are oriented toward the distal opening of the body. The widthacross the top face of a flexible appendage may be narrower at the baseportion than the outer portion. In some embodiments, the width acrossthe top face is at least twice the distance as a thickness measuredperpendicular to the top face. The thickness of a flexible appendage, asmeasured perpendicularly from the top face, is between 0.1-0.9millimeters.

Some attachable structures may be tubular and comprise a lumen. Some maytake the form of a cap that is configured to be coupled to the distalend of an endoscope. In some embodiments, the attachable structure isconfigured to stretch around the shaft of an endoscope. The structuremay be configured to be rolled up the shaft of the endoscope in certainimplementations.

Some attachable structures may be configured to extend around a portionof an endoscope shaft. For example, they may extend 90-360° around anendoscope shaft. In some implementations, the attachable structure mayinclude a clip for attachment to the shaft of an endoscope. Theseembodiments may also include fastening mechanisms for securing the clipto the shaft. The fastening mechanism, in some embodiments, may includea hinge.

Some attachable structures are movable along the endoscope shaft. Someembodiments include an elongate sheath configured to fit tightly aroundthe shaft of an endoscope. In some embodiments, the sheath is the bodyof the attachable structure. In others cases, one or more bodies ofattachable structures may be positioned radially outward from thesheath. The sheath, in some implementations, may be a mesh.

A balloon access device for use with an endoscope is also disclosedherein. The endoscope comprises a shaft extending between proximal anddistal ends. An imaging system may be located partially located on adistal face of the endoscope. The imaging system includes anillumination system, also located at least partially on the distal faceof the endoscope.

The balloon access device further includes a balloon that is configuredto be positioned at a distal end of an endoscope. The balloon isexpandable from a deflated shape to an inflated shape. It includes aproximal end and a distal end having a dome portion. A portion of theproximal end may be positioned over a component of the imaging systemwhen the balloon is positioned at the endoscope distal end and in itsinflated shape, such that imaging using the endoscope comprises thetransmission of light through the proximal and distal ends of theballoon. The component of the imaging system may include a lens or acamera.

The balloon access device further includes at least one of theaforementioned attachable structures. The attachable structure of theballoon access device is configured to induce intestinal pleating whenan inserted endoscope is pulled back toward an opening of a bodilycavity. These structures are configured to be coupled to the endoscope,either at the distal end and/or along the shaft. The attachablestructure includes a body having a proximal end and a distal end, anopening extending between the proximal and distal ends, and at least oneflexible appendage extending outwardly from the body. At least oneattachable structure contacts the balloon when the balloon is positionedat the endoscope distal end and in its inflated shape, such that imagingusing the endoscope comprises transmission of light through the proximaland distal ends of the balloon.

The balloon of the balloon access device may be configured to seal withthe attachable structure. The attachable structure may include a balloonsealing portion proximate to its distal end. The balloon sealing portionmay have a circular groove that retains and seals with a circular rib ofthe balloon. In some embodiments, the inner portion of the attachablestructure may include a rib and a balloon sealing portion, and theproximal end of the balloon contacts the balloon sealing portion and therib. In other embodiments, the attachable structure body may include anoutwardly flaring balloon sealing portion, which prevents the balloonfrom being unseated from the attachable structure. The at least oneflexible appendage may extend outwardly from the balloon sealingportion. In still other embodiments, the proximal end of the balloon mayinclude a collar with at least one engaging portion that is configuredto engage the attachable structure adjacent the distal end of theendoscope.

The attachable structure of the balloon access device may include anendoscope receptacle for receiving the distal end of the endoscope. Thereceptacle may extend into the attachable structure through its proximalend. It may include a stop that engages the front face of the endoscopewhen the endoscope is received within the attachable structure. Theopening may extend through the stop to distally expose at least onecomponent of the imaging system on the distal face of the endoscope.

Multiple attachable structures may be spaced along the shaft of theendoscope. In some embodiments, the length of the flexible appendages ofthe attachable structure at the distal most point along the endoscopeshaft is shorter than the lengths of appendages of at least one of theother attachable structures. For example, the lengths of the flexibleappendages of the attachable structures increase moving proximally alongthe endoscope shaft. In some embodiments, the length of the flexibleappendages of an attachable structure is 0.1-1 mm shorter than theflexible appendages of a proximally spaced attachable structure.

Methods of visualizing the internal surface of an intestinal cavityusing intestine pleating attachable structures are also disclosed. Themethods includes providing at least one attachable structure that may beattached to an endoscope shaft. The method furthers include attachingthe attachable structure to the endoscope such that it extends at leastpartially around the shaft of an endoscope, with the flexibleappendage(s) extending outwardly from the shaft of the endoscope.

Methods for visualizing the internal surface of an intestinal cavityinclude positioning the endoscope within an intestinal cavity of asubject, such that the flexible appendage of the attachable structurecontacts the intestinal wall. The method may further include pushing onthe shaft of the endoscope to cause a forward advance of the distal endof the endoscope within the intestinal cavity, and pulling back on theshaft of the endoscope. The step of pulling back causes the flexibleappendage to move the intestinal wall relative to the imaging systemcomponent located on the distal, face of the endoscope. This may reducelooping of the intestine.

Methods for visualizing the internal surface of an intestinal cavity mayfurther include promoting contact between the flexible appendage and theintestinal wall. Promoting contact may include performing the methodwithout insufflation of the intestinal cavity.

Attaching the at least one attachable structure may include stretchingthe attachable structure around the shaft of the endoscope. It may alsoinclude positioning one or more attachable structures along the shaft ofthe endoscope, spaced proximally from the attachable structure locatedadjacent the distal face of the endoscope. This may be accomplished byrolling the attachable structures proximally along the shaft. In otherembodiments, an elongate sheath may be included. The elongate sheath mayfit tightly around the shaft of the endoscope, and the attachablestructures may be attached to the outside of the sheath. In theseembodiments, positioning one or more attachable structures along theshaft of the endoscope comprises positioning the sheath around theshaft. This may be accomplished by pulling the sheath over the distalface of the endoscope, for example.

Pulling back on the shaft of the endoscope may include moving theintestinal wall relative to the imaging system component, and draggingthe intestinal wall into a pleated formation. This pleated formation mayfacilitate a forward advance of the distal face of the endoscope. Thestep of pulling back on the shaft of the endoscope causes the flexibleappendage to flip directions. Methods for visualizing the internalsurface of an intestinal cavity may further include pushing theendoscope forward, for example, beyond the pleated formation, afterpulling back on the shaft of the endoscope. This forward movement maycause the flexible appendage to flip directions.

Methods for visualizing the internal surface of an intestinal cavity mayfurther include activating the endoscope imaging system to providevisual images of the intestinal wall to a user. A balloon may beprovided for inflation adjacent the distal end of the endoscope. Themethods may include positioning the balloon over the imaging componentof the endoscope, such that activating the imaging system causes lightto be transmitted and received through distal and proximal ends of theballoon. When a balloon is provided, the attachable structure may be acap configured to encircle the distal end of the endoscope. Positioningthe balloon over the imaging component of the endoscope may includemaking contact between the cap and the balloon.

DESCRIPTION OF DRAWINGS

FIG. 1 is an isometric view of an embodiment of a transparent balloonaccess device deployed on an endoscope.

FIG. 2 is an isometric view of the balloon access device with thetransparent balloon shown in a normal unexpanded dome shape.

FIG. 3 is an isometric exploded view of the balloon access device

FIG. 4 is an isometric view of the balloon access device with theballoon shown collapsed by drawing a vacuum prior to being inserted intoan adjacent balloon insertion tube.

FIG. 5 is an isometric view of the balloon access device with a balloonseal cap placed on a distal end of the scope and with a dashed lineillustrating a path where the balloon access device can enter an openinstrument channel which exits within the attached balloon seal cap.

FIG. 6 is a side section view of the flexible shaft of the endoscopewith an un-inflated balloon being pushed longitudinally along aninstrument passage of the endoscope.

FIG. 7 is a side view showing the balloon after emerging from a distalend of the endoscope.

FIG. 8 is a side view showing the balloon inflated after emerging from adistal end of the endoscope.

FIG. 9 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 10 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 11 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 12 shows an exploded cross sectional view of an embodiment of theballoon and balloon seal cap.

FIG. 13 shows the balloon of FIG. 12 in a normal un-inflated shapewherein the inner air pressure is the same as the outside atmosphericpressure.

FIG. 14 shows the balloon of FIG. 12 in an inflated shape where about2.5 ml of air have been placed into the balloon and cannula.

FIG. 15 shows the balloon of FIG. 12 in an inflated shape where about3.5 ml of air have been placed into the balloon and cannula.

FIG. 16 shows the balloon of FIG. 12 in an inflated shape where about 5ml of air have been placed into the balloon and cannula.

FIG. 17 is a side cross sectional view of the balloon access deviceinstalled upon an endoscope as the balloon access device spreads tissueto burrow through non-insufflated and collapsed luminal tissue.

FIG. 18 is an enlarged side cross sectional view of the balloon accessdevice of FIG. 17 showing spreading forces on the collapsed luminaltissue.

FIG. 19 is a view through the camera lens of the endoscope showing aguide tip of the balloon moved to a centered position in a collapsedtissue lumen opening to ensure passage of the balloon and endoscope downa center of the lumen.

FIG. 20 is a cross sectional view of a blow molding dies that isconfigured to make the balloon of FIG. 12.

FIG. 21 is an isometric view of a clamp mechanism to clamp or lock thetensioned cannula relative to the endoscope to maintain a sealingcontact between balloon and seal cap.

FIG. 22 is a front view of a distal end of an endoscope.

FIG. 23A is a side section of an endoscope with an inflated balloon.

FIG. 23B is a side section of an endoscope with another embodiment of aninflated balloon.

FIG. 23C is a side section of an endoscope with another embodiment of aninflated balloon.

FIG. 24 is a perspective view of a balloon.

FIG. 25A is a side section of a balloon.

FIG. 25B is a tranverse section of a balloon along the section linedesignated in FIG. 25A.

FIG. 25C is a tranverse section of a balloon along the section linedesignated in FIG. 25A.

FIG. 25D is a tranverse section of a balloon along the section linedesignated in FIG. 25A.

FIG. 26 is a perspective view of a balloon including longitudinalgrooves.

FIG. 27 is a perspective view of a balloon including longitudinalgrooves and trusses.

FIG. 28A is a cross section of an attachable structure with a single rowof flexible appendages.

FIG. 28B is a cross section of an attachable structure with multiplerows of flexible appendages.

FIG. 29A is a top view of an attachable structure with a unitaryflexible appendage.

FIG. 29B is a top view of an attachable structure with multiple flexibleappendages extending outwardly from the attachable structure.

FIG. 29C is a top view of an attachable structure with multiple flexibleappendages extending outwardly from the attachable structure.

FIG. 30A is a cross section of an endoscope and balloon access deviceutilizing an attachable structure with flexible appendages. Theendoscope is being pushed forward within a non-insufflated intestinalcavity.

FIG. 30B is a cross section of an endoscope and balloon access device ofFIG. 32A utilizing an attachable structure with flexible appendages. Theendoscope is being pulled backward within a non-insufflated intestinalcavity.

FIG. 31A is an isometric view of an endoscope and balloon access deviceutilizing attachable structures with flexible appendages.

FIG. 31B is an isometric view of an endoscope and balloon access deviceutilizing groupings of attachable structures with flexible appendages.

FIG. 32 is a side view of an endoscope with attachable structures havingflexible appendages. This embodiment also includes a sheath to aidpositioning of the attachable structures along the endoscope shaft.

FIG. 33A is a side cross section of an attachable structure withappendages biased toward the proximal opening of the attachablestructure body.

FIG. 33B is a side cross section of an attachable structure withflexible appendage tips pointing away from the proximal opening of theattachable structure body.

FIG. 33C is a tip view of an attachable structure demonstrating agreatest width w of the attachable structure as measured between thetips of opposite appendages.

DETAILED DESCRIPTION

The following description of certain examples of the medical apparatusshould not be used to limit the scope of the medical apparatus. Otherexamples, features, aspects, embodiments, and advantages of the medicalapparatus will become apparent to those skilled in the art from thefollowing description, which is by way of illustration, one of the bestmodes contemplated for carrying out the medical apparatus. As will berealized, the medical apparatus is capable of other different andobvious aspects, all without departing from the spirit of the medicalapparatus. Accordingly, the drawings and descriptions should be regardedas illustrative in nature and not restrictive.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

FIG. 1 is an isometric view of one embodiment of a balloon access device30 installed upon an endoscope 100. The balloon access device 30 isconfigured to fit within an operative channel 102 of the endoscope 100when undeployed, and to deploy a transparent hollow balloon 60 across adistal face 104 of the endoscope 100. The balloon 60 is transparent sothat scope optics can view GI tissue there through, and balloon 60 canbe dome shaped on at least a distal end. A distally located guide tip 62is supported solely on a distal end of the dome shape by a membrane wall65 of the balloon 60. The configuration of the deployed guide tip 62 andballoon 60 on the endoscope 100 is such that non-insufflated GI tissuecan be parted and spread with the tip 62 and the balloon 60 in responseto pushing with the endoscope 100. The balloon access device 30 andendoscope 100 as configured can rapidly burrow along a non-insufflatedand at least partially pinched GI tract such as the non-insufflatedlower GI tract, or can pass through an expanded or insufflated portionof the GI tract. As will be described in detail later, the deployedtransparent guide tip 62 can be visually aimed at a center of thecollapsed lumen of the non-insufflated GI tract by articulating a distalend 106 of the endoscope 100. When the guide tip 62 is aimed, pushingthe endoscope 100 initiates the spreading and parting of the collapsedtissue walls with the balloon access device 30, thereby enabling passageof the endoscope 100 along a center of the non-insufflated lumen of theGI tract.

As shown in FIG. 1, the balloon access device 30 is shown inserted intoan operative channel 102 of the endoscope 100 and comprises a proximalhandle portion 50 extending from a proximal opening of the operativechannel 102. A biopsy valve 108 is provided on the proximal opening ofthe operative channel 102 and a hollow catheter 70 extends from theproximal handle portion 50, through the biopsy valve 108, and into theoperative channel 102. A distal end of the catheter 70 is secured to aproximal end of the transparent balloon 60 shown extending across adistally located front face 104 of the endoscope 100.

A balloon seal cap 40 of the balloon access device 30 is removablysecured to the distal end 106 of the endoscope 100 and forms a fluidtight seal with at least one surface on a proximal end of the balloon60. Alternatively, it will be appreciated that the cap 40 may beintegral with the endoscope. The seal cap 40 may be any suitable shape,such as cylindrically shaped. The sealing interaction of the seal cap 40with the endoscope 100, and the balloon 60 with the seal cap 40, cancreate a sealed volume across the front face 104 of the endoscope 100 toprevent the egress of unwanted fluids across the optical lens 105 of anendoscope camera located on the front face 104 (see FIG. 17).Additionally, once the seal is formed, the balloon 60 can be furthersecured to the seal cap 40 by applying a vacuum to the operative channel102 to draw the balloon 60 into further engagement with the seal cap 40.Alternately, a vacuum port (not shown) in the endoscope 100 can be usedto draw the balloon 100 against the front face 104 of the endoscope. Theballoon device 30 can be rapidly deployed and inflated into place on theendoscope 100 for advancement, and rapidly deflated and withdrawn fromthe operative channel 102 of the endoscope 100 for the insertion anddeployment of another surgical instrument from the operative channel 102into the lower GI tract. An example of such another surgical instrumentcan be, but is not limited thereto, a snare or tissue biopsy device toretrieve a tissue sample from a suspect site.

FIG. 2 shows an isometric view of the balloon access device 30. Thehandle or proximal handle portion 50 includes a hollow passage 72 thatextends longitudinally through the handle portion 50, through the hollowcatheter 70, and operatively connects to an inner volume of the balloon60. Handle portion 50 includes a proximal luer lock 52 to removablyengage hollow passage 72 with compressed gas and/or vacuum lines and orfluid lines, a valve 54 to control the flow of gas and vacuum to thedistal balloon 60, a grip 56, and orientation wings 58. Hollow catheter70 can be configured to have sufficient length to work with an endoscope100 as described above, or tong enough to work with a variety ofendoscopes 100 with differing lengths.

In FIGS. 2 and 3, the transparent balloon 60 is shown in the normalunpressurized or “as manufactured” shape wherein the hollow balloon 60can have a distal dome 64 and at least one sealing surface 66 on aproximal side. The balloon 60 is configured to be symmetrical andconcentric about a longitudinal axis of the balloon 60 and alongitudinal axis of the catheter 70, and the distal dome 64 can behemispherical or elliptical in shape about the axis. The balloonincludes a proximal collar 63 which includes a proximal elongatedprojecting portion 68 and a base portion 66. The proximal collar 63securely seals the balloon 60 to the catheter 70 via an attachmentmethod such as but not limited thereto, by an adhesive or a shrink fitas described later. Elongated projecting portion 68 may have a shapedportion that is cylindrical, pyramidal, tapered, or bulbous, and caninclude a conical or curved portion for engaging with or sealing withthe operative channel 102 of endoscope 100. The guide tip 62 can be aseparate piece that can be secured to the dome of the balloon 60 in theexemplary manner. As best shown in FIG. 3, the guide tip 62 has arounded distal tip and a stepped proximal post 69 that can be adhesivelysecured into a distal collar 67 formed from the balloon membrane 65.Alternately, the guide tip could be a rounded bump formed from theballoon membrane 65, or an injection of sealing material into the distalcollar 67 such as a gob of silicone placed inside the distal collar 67.The guide tip 62 can be transparent for visualization therethrough, orcan be opaque or translucent. As shown, guide tip 62 is supported byonly the balloon membrane 65 which can provide some freedom of motion ofthe tip 62 relative to the endoscope 100. This freedom of motion canbeneficial when navigating through collapsed tissue A hollow ballooninsertion tube 80 is shown distal to the guide tip 62 may be provided toreceive and store the balloon 60 and tip 62 within when the balloon isdeflated by drawing a vacuum prior to being inserted into an adjacentballoon insertion tube 80, and tube 80 can have a length sufficient toguide the balloon 60 and tip 62 into and beyond a “Y” portion of theoperative channel 102 within the endoscope 100. A deflated balloon 60 isshown in FIG. 4 just prior to insertion within a hollow of the ballooninsertion tube 80. Before insertion, balloon 60 may have one or moredeflation folds of the balloon 60 wrapped or twisted about alongitudinal axis of the balloon (not shown) to create a more compactand organized deflated balloon 60.

FIG. 5 shows the access device 30 ready for installation onto theendoscope 100. In this view, the cylindrical seal cap 40 is positionedfor placement onto the distal end 106 of the endoscope 100. The balloon60 is fully deflated as shown in FIG. 4, and resides within the ballooninsertion tube 80. A dashed line is provided to show how the ballooninsertion tube 80 of the access device 30 can be inserted into theproximal opening of the operative channel 102 of endoscope 100, and if abiopsy valve 108 is provided, through the biopsy valve 108. The ballooninsertion tube 80 can be configured to feed the balloon 60 directly intothe operative channel 102 through the balloon insertion tube 108 withthe guide tip 62 leading the collapsed balloon. Balloon insertion tube80 can be the length as shown, or can be longer to guide the collapsedballoon past a “Y” within operative channel 102 Balloon insertion tube80 can be constructed from a slick or lubricious plastic such as PTFE,or can be lubricated to reduce egress of the collapsed balloon 60 intoor out of the tube 80. FIG. 1 shows how the balloon insertion tube 80can be retracted proximally around the catheter 70 to a positionadjacent to the handle portion 50 after the full insertion of the accessdevice 30 into the operative channel 102.

FIG. 6 shows the fully deflated balloon as it is being pushed downchannel 102 of the endoscope 100 prior to emergence of the balloon 60from the distal face 40 of the endoscope 100. The guide tip 62 can beconfigured with a tip diameter that is close to the inner diameter ofthe operative channel 102 of the endoscope 100, and an appropriatelength so that the tip 62 will not cock and jam within the operativechannel 102 of the scope 100. The tip of the guide tip 62 can be anyshape that is conducive to steering the guide tip along the operativechannel 102 such as the rounded tip 62 shown, or any other guiding shapesuch as but not limited to a cone.

FIG. 7 shows the balloon 60 after emerging from the distal end 106 ofthe endoscope 100. Once the balloon 60 is extended from the endoscope 60and beyond the seal cap 40, atmospheric air may be induced through thehollow passage 72 to allow the balloon 60 to expand into thenon-pressurized shape as shown. Once the balloon 60 is fully inflatedwith a fluid, such as air, to an operating pressure or volume, theballoon 60 is pulled proximally in the direction of the arrow to engagethe balloon 60 with the seal tip 40. This pulling of the balloon 60 toseal against the seal tip 40 can be accomplished by pulling on thecatheter 70 or the handle portion 50 outside of the patient. Ifrequired, the balloon 60 is free to pivot somewhat about the attachmentpoint to the catheter 70 to center itself in the seal cap 40.

FIG. 8 shows the fully inflated balloon 60 pulled against the seal cap40 at the distal end 106 of the endoscope 100. In this view, it can beseen that the inflation of the balloon 60 has changed the at least onebase portion 66 of proximal collar 63 into a rounded dome that hasmaintained a fluid-tight seal with the seal cap 40. The rounding of theat least one base portion 66 has moved the distal dome 64 distally, andthe distal dome 64 has expanded both in diameter and longitudinally asshown. The inflation of the balloon 60 can be accomplished prior toinsertion of the endoscope 100 into the patient, or after insertion ofthe endoscope 100 into the natural orifice such as the anus of thepatient.

FIGS. 9 through 12 shows exploded cross sectional views of alternateexemplary embodiments of the balloon 60, and balloon seal cap 40 of thepresent apparatus. The guide tip 62 is also depicted. The exemplary andpreviously described embodiment of balloon 60 and seal cap 40 is bestshown in FIGS. 2, and 3, and is shown in cross section in FIG. 11. Thereader is advised to note that the balloon access device 30 is notlimited to the previously described embodiment of FIG. 11, nor to thealternate embodiments of FIGS. 9-10 and 12, nor to any of the materialsor manufacturing techniques described. Since many of the embodiments ofthe balloons and seal caps have features that perform the same function,like numbers are identified with sub-identifiers and are meant tocorrespond to like features on alternate embodiments. For example, aballoon 60 in one embodiment may become a balloon 60 a in anotheralternate embodiment. If differences in functions exist between likenumbers such as base portions 66 and 66 a, the description associatedwith the number and sub-identifier will prevail for that embodiment. Allembodiments described below have a balloon 60, 60 a, 60 b, 60 c and aseal cap 40, 40 a, 40 b, 40 c.

The embodiment of FIG. 11 comprises the hollow balloon 60, the balloonseal cap 40 and the guide tip 62. This embodiment uses a ring-in-grooveseal between the balloon and seal cap 40. The balloon 60 comprises thepreviously described distal dome 64, the membrane 65, and the at leastone base portion 66 of the proximal collar 63. With this embodiment ofthe balloon 60, the at least one base portion 66 of the ballooncomprises two distinct portions. The first portion comprises a circularrib 61 that rings the longitudinal axis of the balloon 60 and isconfigured to engage with and seal with the circular groove 41 in theseal cap 40. The second portion of the at least one base portion 66 is adish shaped portion that extends substantially radially inwardly betweenthe largest diameter of distal dome 64 to the circular rib portion. Thedish shaped portion can be configured to seal against at least a distalmost surface 48 of the cap 40. The distal collar 67 of balloon 60extends distally from the dome 64 and is configured to seal with thedistal tip 62. The elongated projecting portion 68 of the proximalcollar extends proximally from the at least one base portion 66 and isconfigured to seal with the hollow catheter 70 (see FIGS. 2 and 3).

The balloon seal cap 40 of FIG. 11 comprises a hollow cylinder having anendoscope receptacle 42 extending into a proximal end of the seal cap 40to receive and seal with the distal end 106 of the endoscope 100. Acircular rib 45 can be provided at a distal end of the endoscopereceptacle 42 to act as a stop that engages the front face 104 of theendoscope 100 once the scope 100 is fully received within the seal cap40. An opening 46 is provided through the rib 45 to distally expose theoptics, lights, and openings on the endoscope front face 104. A balloonsealing portion 44 extends distally from the rib 45 and includes thepreviously described circular groove 41 to retain and seal with thecircular rib 61 of the balloon 60. The distalmost surface 48 of theballoon sealing portion 44 can seal with the balloon 60. As shown, thereceptacle 42, the opening 46, and the balloon sealing portion 44comprise the open hollow of the cylindrical seal cap 40.

The embodiment of FIG. 9 comprises a balloon 60 a and a seal cap 40 aand is configured to provide a ball-in-socket type of sealing. Theballoon 60 a has a substantially curved base portion 66 a that nestswithin and seals with an outwardly flaring cuplike balloon sealingportion 44 a of the seal cap 40 a. Seal cap 40 a can be configured toflare outward to provide a larger support for the balloon 60 a and canexceed the diameter of the endoscope 100. Seal cap 40 a is a hollowcylinder that further comprises an endoscope sealing receptacle 42 a,circular rib 45 a, opening 46 a, as well as the previously describedballoon sealing portion 44 a. Balloon 60 a includes a distal dome 64 a,a membrane 65 a, a distal collar 67 a, and a proximal elongatedprojecting portion 68 a. Cuplike balloon sealing portion 4 a of the sealcap 40 a can also be used to flatten luminal folds, for example todiscern pathologies behind the luminal folds.

The embodiment of FIG. 10 comprises a balloon 60 b and a seal cap 40 band uses peg-in-hole arrangement for sealing. In this embodiment, theballoon 60 b is sized to have about the same radial diameter as thedistal end 106 of the endoscope and the balloon 60 b nests and sealswith a receptacle of a cylindrical balloon sealing portion 44 a.Mushroom shaped balloon 60 a comprises a distal dome 64 with at leastone base portion 66 a that is substantially flat and circular. Balloon 6b is configured to fit snugly in the cylindrical balloon seating portion44 a and to seal the at least one sealing surface 66 a against a rib 45b. Cylindrically shaped cap 40 b further comprises an endoscope seatingreceptacle 42 b, and an opening 46 b extending through rib 45 b. Balloon60 b includes a distal dome 64 b, a membrane 65 b, a distal collar 67 b,and an elongated projecting portion 68 b.

The embodiment of FIG. 12 comprises a balloon 60 c and seal cap 40 cthat is configured to provide a flat-to-flat seal as the balloon 60 c ispulled against a distalmost surface 48 c of seal cap 40 c. As theinflating balloon 60 c changes shape from the mushroom shape to arounded elliptical ball shape, the seal can move to a beveled portion ofa distal balloon sealing portion 44 c. Balloon 60 c may be substantiallymushroom shaped with a substantially flat at least one sealing surface66 c adjacent to a dome 64 c. Unlike the embodiment of FIG. 10, theballoon 60 c is larger than an outer diameter of a seal cap 40 c andoverhangs the seal cap 40 c. Cylindrically shaped cap 40 c furthercomprises an endoscope sealing receptacle 42 c, circular rib 45 c, andopening 46 c. Balloon 60 a further comprises a distal dome 64 a, amembrane 65 a, a distal collar 67 a, and an elongated proximalprojecting portion 68 a.

The balloons 60, 60 a, 60 b, and 60 c are transparent and can beconstructed from a substantially rigid balloon material or anelastomeric material.

Substantially rigid materials cannot expand greatly beyond the normal“as made” shape when inflated and many such materials are well known inthe art for use as expansion balloons for cardiac stent deploymentproducts. Elastomeric balloons are expandable, and can comprise materialsuch as, for example, some grades or durometers of elastomers such aspolyurethane, latex, natural rubbers, silicones and the like.

The seal caps 40, 40 a, 40 b, and 40 c can comprise a substantiallyrigid material such as a thermoform plastic, a thermoset plastic, or ametal. With rigid embodiments of the caps, it is the deformation of theballoon 60, 60 a, 60 b, and 60 c against the rigid cap that creates theseal. In yet another embodiment, the seal caps 40, 40 a, 40 b, and 40 ccan comprise an elastomeric material such as but not limited to apolyurethane, a polyethylene, silicone, rubber and the like. As such,the elastomeric properties of this embodiment can have sufficientrigidity to generally support the balloon against normal surgicaloperating forces, yet provide atraumatic characteristics, shouldsubstantial resistance be encountered. Rigidity of the elastomericmaterial could be altered by changing a durometer of the material duringmanufacturing.

Alternately, the distal balloon sealing portion 44, 44 a, 44 b, 44 c ofthe caps 40, 40 a, 40 b, and 40 c could be rigid or elastomeric and canfurther comprise one or more deformable gasket materials to create aseal such as but not limited to: an elastomeric lip seal, an o-ring, anover-molded elastomer, or a foam seal (not shown). Such seals can sealwith the balloon 40, the endoscope 100 or both.

The distal guide tip 62 can be used with any balloon embodiments such as60, 60 a, 60 b, and 60 c. The distal guide tip 62 can include thestepped proximal post 69 which is configured to fit within the distalcollar 67, 67 a. 67 b, or 67 c to create a smooth exterior when matedwith the balloon 60, 60 a, 60 b, or 60 c (see at least FIGS. 1 & 2). Theguide tip 62 and catheter 70 can be adhered to the balloon 60, 60 a, 60b, or 60 c with adhesives such as but not limited to polyurethanes orcyanoacrylates. Or, alternate fastening techniques can be used withdistal guide tip 62 and catheter 70 such as but not limited to heatstaking, ultrasonically welding, or laser welding. Whereas thesefastening techniques are described for the attachment of the distalguide tip 62, they can be used for all other embodiments of theapparatus such as elements of the handle portion 50 or attachment of theproximal collar 63 to the catheter 80.

FIGS. 13-16 are side views that detail the inflation of the distalportion of the balloon access device 30 on the endoscope 30. Themushroom shaped balloon 60 c and cap 40 c are the embodiments shown incross section in FIG. 12. For this inflation description, only theembodiment of FIG. 12 will be described, and the description is based onphysical measurements of an actual balloon 60 c and cap 40 c as theballoon 60 c is inflated.

FIG. 13 shows balloon 60 c in a normal un-inflated normal shape whereinthe inner air pressure is the same as the outside atmospheric pressureand the balloon 60 c has assumed the “as manufactured” mushroom shape.As shown, the normal shape of balloon 60 c is substantially mushroomshaped, and comprises the distal dome 64 c attached to the proximal atleast one base portion 66 c. The at least one base portion 66 c issubstantially flat and has been pulled back (via catheter 70) to sealagainst a ring of contact with the ring shaped distalmost surface 48 cof the seal cap 40. With atmospheric pressure within balloon 60 c, andthe valve 54 of the handle portion 50 closed, the balloon 62 is veryflaccid and the guide tip 62 is substantially supported by only themembrane 65 c. Pushing the guide tip 62 towards the catheter 70 createsa large indention crater with the tip 62 standing proud within as thetip 62 is completely pushed into the dome 64 c. Measurements of theballoon 60 c of FIG. 13 show an outer dimension D1 of about 18 mm at thewidest diameter, and the sum of longitudinal lengths A1 and B1 equalabout 11 mm. The balloon 60 c and catheter 70 of the actual test balloon60 c required about 2-2.1 ml of air to arrive at the flaccid shape ofFIG. 13.

FIG. 14 is another side view of the access device 30 on the endoscope100 where about 2.5 ml of air have been placed into the balloon 60 c andcatheter 70. At this air volume, the distal dome 64 c maintainedsubstantially the same shape, but the at least one base portion 66 cdomed slightly and pushed the distal dome 64 c and guide tip 62 in thedistal direction. This increased the sum of longitudinal lengths A2 andB2 to about 11.7 mm without an appreciable change in D2. It is visuallyseen that the majority of the 0.7 mm balloon longitudinal length changeoccurred in the doming of the at least one base portion 66 c whichincreased dimension B2. Pushing on the distal guide tip 62 so that it isembedded within the balloon created a slightly smaller dish shapedindent with the guide tip 62 standing proud in the indent. The increasedvolume of fill also increased the resistance to movement of the tip 62.The balloon 60 c did not appear to move longitudinally from pushing onthe guide tip 62 but expanded radially when filled with 2.5 ml of air.

FIG. 15 is another side view of the access device 30 on the endoscope100 where about 3.5 ml of air have been placed into the balloon 60 c andcatheter 70. Once again, the distal dome 64 c maintained substantiallythe same shape and the at least one base portion 66 c continued to movetowards a dome shape. The longitudinal length (sum of A3 and B3)increased to about 12.2 mm with the majority of the 0.5 mm additionallength increase coming from additional doming of the at least one baseportion 66 c. The dimension D3 increased slightly to 18.73 mm. When theguide tip 62 was pushed distally into the balloon 60 c, the distal guidetip 62 had substantial resistance. Pushing on the distal guide tip 62 sothat it is embedded within the balloon created a noticeably smaller dishshaped indent with the guide tip 62 standing proud in the indent. As theguide tip 62 was embedded into the balloon 60 c, the balloon 60 c alsomoved distally as some of the distal movement of the guide tip 62 wastransferred to the balloon 60 c. Visually, it appears that there isabout the same amount of distal longitudinal movement of the balloon 60c as there is distal embedding of the guide tip 62. The distal movementof the balloon 60 c is primarily in the at least one base portion 66 c.

FIG. 16 is another side view of the access device 30 on the endoscope100 where about 5 ml of air have been placed into the balloon 60 c andcatheter 70. The diameter D4 reduced back to the original 18 mm diameterand the longitudinal length (sum of A4 and B4) increased to about 14.75mm. Once again, the majority of the additional length increase (2.55 mm)appears to be coming from additional doming of the at least one baseportion 66 c. There was some additional rounding of the distal dome 64 cwhich may account for some of the reduction in overall diameter D4 andsome of the length change. With respect to pushing distally on the guidetip 62 with 5 ml of air, the guide tip 62 has substantial resistance andthe combination of balloon geometry (mushroom shape), fill volume (ml)balloon membrane 65 c thickness and material durometer have combined toprovide an unexpected shift in load transfer that seems to prevent theguide tip 62 from creating much of a dish indent in the balloon. Withthis fill volume, a substantial portion of the movement of the guide tip62 towards the catheter 70 comes from a longitudinal compression of theballoon 60 c to a different elliptical shape, and not from dishing theguide tip 62 into the balloon 60. This effect may be advantageous totunneling through non-insufflated tissue lumens to maintain thedistalmost positioning of the guide tip 62 during airless burrowing ofthe access device 30 and the endoscope 100. It is the distalmostposition of the guide tip 62 which can enable the guide tip 62 toinitiate separation of the collapsed luminal tissue. Once the initialseparation occurs, the collapsed tissue separation may then betransferred to the outer surface of the balloon 60 c as the accessdevice 30 and endoscope 100 advances along the GI tract.

FIGS. 17 and 18 are side cross sectional views of the balloon accessdevice 30 installed upon an endoscope 100 as it burrows throughnon-insufflated luminal tissue of the GI tract. FIG. 18 is an enlargedview of a portion of the cross sectional view of FIG. 17. As shown, theluminal tissue has collapsed, and the balloon access device 30 isproviding both a visualization pocket and a tissue separator for theoperator of the endoscope 100 so that the endoscope 100 can be easilyadvanced farther into the patient. An arrow is provided to indicate thedirection of movement of the balloon access device 30 and endoscope 100.In this cross section, the collapsed luminal tissue 200 is partiallyspread by the balloon access device 30 and endoscope 100 as it burrowstowards a bend in the tissue 200. The endoscope 100 is shown in crosssection and has the operative channel 102 and front face 104 shown.Front face 104 of the scope 100 further comprises a lens 105 that viewstissue through the transparent balloon 60. A visualization channel 107may extend through the shaft of the endoscope for relaying images to theuser. An illumination channel 109 and light 111 may also be included onthese or other embodiments to assist in visualization of the intestinalwall.

A viewing angle of the lens 105 is shown as dashed lines extending fromthe lens 105 (see FIG. 18). To prevent reduction of the viewing angle,the cap 40 may protrude above the front face 104 of the scope betweenabout 0.5 mm to about 6 mm. Alternately, the cap 40 may protrude abovethe front face 104 of the scope between about 1 mm to about 3 mm. Ifdesired, the vacuum in the endoscope 100 can be used to draw the balloon100 against the front face 104 and the lens 105 of the endoscope 100.The hollow catheter 70 extends longitudinally along the operativechannel 102 and is attached to the balloon 60 which is inflated (via thecatheter 70) an amount that substantially restricts the embedding of theguide tip 62 into the balloon as described previously. The cap 40 issealed against the endoscope and the balloon 60 is sealed within the cap40 to seal the front face 104 of the endoscope 100 from fluids, mucous,and residual natural materials normally found within the luminalstructure. As shown, ring 61 of the balloon is embedded in the groove 41in the seal cap 40 to create a seal.

FIG. 18 is an enlarged side cross sectional view of FIG. 17. In thisview, the spreading of the collapsed opening 204 of the tissue 200 canbe seen through the transparent balloon 60. The lens 105 of theendoscope can be seen with dashed lines indicating a field of viewthrough the balloon access device 30. Arrows show how a spreading forceF1 is applied from the guide tip 62 onto the tissue 200. The guide forceF1 is perpendicular or normal to the point of contact on the tissue. Asecond spreading force F2 is exerted on the tissue by the inflatedballoon 60. Once again, the spreading force F2 is perpendicular ornormal to the point of contact of the membrane 65 of the balloon 60 onthe tissue.

FIG. 19 is a view through the lens 105 of the camera of the endoscope100 looking at collapsed tissue through the transparent balloon 60 andguide tip 62. In this view, the surgeon has steered the guide tip 62 ofthe balloon 60 to a centered position of the collapsed tissue opening204 of the tissue 200. Since the tissue guide 200 is transparent, tissue200 can be seen therethrough. Once the guide tip 62 of the balloon 60 iscentered, the surgeon is confident that the balloon access device 30 andendoscope 100 are aimed at the center of the collapsed lumen, and thatthe balloon access device 30 and endoscope 100 can now be pushed down acenter of the lumen such as the large intestine. During testing of thedevice in actual tissue, several of the medical professional operatorswere surprised at the depth of penetration of the balloon access device30 equipped endoscope 100 in such a short time.

FIG. 20 is a cross sectional view of a blow molding dies that isconfigured to make the balloon of FIG. 12. As shown, the blow moldingdie 210 has a piece of expandable polyethylene tubing 220 placed along alongitudinal axis of the balloon shape of the die 210. Once the tubing220 is heated, warm compressed air can be blown to expand thepolyethylene tubing 220 against the cooler inner walls of the mold 210which can be held slightly below the melting temperature of thepolyethylene tubing 220. When the flow of warm expansion air is shutoff, the tubing 220 has expanded against the walls of the mold 210 andsets in the net or normal “as manufactured” shape. Then the moldedballoon 60 can be extracted by opening the die 210 to release theballoon 60. The dashed lines show the expansion stages of thepolyethylene tubing 220 as it expands towards the mold walls 210. Thenatural tendency of the hot tubing 220 is to expand as a sphere untilthe expanding material contacts the watts of the die 210. As aconsequence, different portions of the balloon membrane 65 (see FIG. 2)will be thinner than others and may taper between the thick and thinportions. For example, the portions of the tubing 220 that form theelongated projecting portion 68 and distal collar 67 will expand not atall or very slightly and will be thicker than the balloon membrane 65 atthe points of largest expansion away from the longitudinal axis. Theshape of the balloon can affect the location of the thick and thinmembrane 65 portions and a stiffened disk may be found near theelongated projecting portion 68 and distal collars 67, which can affectthe manner in which the balloon 60 expands (see FIGS. 13-16). Thisthickening could affect or restrict the displacement of the guide tip 62from tissue contact by creating a more rigid “island” of membrane 65around the distal tip 62 that may explain the deflection behaviordescribed previously. In an alternate embodiment, the balloon 60 can befurther stiffened in local areas by a dipping process to build up theballoon wall thickness. For example, the same material as the balloonmembrane 65 can be used (such as polyurethane), or alternate dippingmaterial may be used.

With some embodiments of the balloon such as that found in FIG. 12, atension or pulling force may be applied to the catheter 70 to pull theballoon 60 c into contact with the seal cap 40 c to create a seal. Itmay be further desirable to include a lock or clamp mechanism 250 tohold the catheter 70 relative to the endoscope to ensure that the fluidtight seal is maintained in all tissue contacting situations. FIG. 21illustrates an embodiment of a clamp mechanism 250 that can be used toclamp or lock the tensioned catheter 70 relative to the endoscope 100 tomaintain a sealing contact between balloon 60 c and seal cap 40 c. Clampmechanism 250 comprises a releasably lockable clamp mechanism thatcontacts and grips catheter 70 and is actuated and released via a pullmember 252 to clamp the catheter 70. Alternate clamp mechanisms such asclamp mechanism 260 can surround the catheter 70 and retain it in placevia frictional contact. One example of clamp member 260 would be abiopsy valve 108 or an adaption thereof wherein the biopsy valve 108grips the endoscope 100 and the catheter 70 with an elastomericmaterial. And, in yet another embodiment of a clamp mechanism, theproximal balloon collar 63 may be configured to expand within theoperative channel 102 of the endoscope 100 to lock the inflated balloonto the end of the endoscope. When the balloon is deflated, the proximalcollar 63 unlocks from the operative channel 102.

Turning now to FIG. 22, a front view of the front face 104 of theendoscope is shown. The operative channel 102 of the endoscope isnon-concentrically disposed in the endoscope, and accordingly thecatheter 70 and balloon are non-concentrically disposed relative to acentral axis of the endoscope. As described previously, when the cap 40and balloon 60 are installed on the endoscope, pulling on the catheterseals the balloon 60 against the cap 40 and the non concentricallydisposed balloon 60 is free to pivot somewhat about the attachment pointto the catheter 70 to center itself in the seal cap 40.

During operation, as the balloon 60 pushes tangentially against theintestinal wall, the force attempts to unseat the balloon from the cap.The flaring portions of the cap, shown in FIG. 9 for example, seat theballoon to prevent the seal between the balloon and the cap from beingbroken or otherwise compromised. Additionally or alternatively, the cap,for example the cap shown in FIGS. 9-12, may include one or morelongitudinal cuts in a portion of the cap protruding past the distal end106 of the endoscope to prevent the balloon from being unseated from thecap when the balloon pushes against the intestinal wall. Alternatively,the portion of the cap protruding past the distal end 106 of theendoscope may have portions of varying heights to seal with the balloon.

FIGS. 23-29 depict balloon and endoscope embodiments that are configuredfor use with or without cap 40. These balloon embodiments may optionallyhave the same or similar dimensions as balloon 60 c of FIGS. 13-16. Asdemonstrated in the cross sections of FIGS. 23A-C, the balloons 60 d, 60e, and 60 f may be positioned such that the elongated projecting portion68 of proximal collar 63 inflates to contact the operative channel 102of the endoscope. After at least partial inflation, the user may pullback on the catheter 70 to bring the base portion 66 of proximal collar63 into contact with the lens 105 (over the visualization channel 107).The transparent nature of the balloon allows for the visualization ofthe intestinal surfaces through both the proximal and distal ends of theballoon 60 d, 60 e, or 60 f. Inflation of the proximal projectingportion 68 against the wall of the operative channel 102 stabilizes theballoon to prevent it from sliding off the lens 105. This improves theclarity of the image that is transmitted to the user thoughvisualization channel 107 by preventing fluids from reaching the lens105. An illumination channel 109 and light 111 may also be included onthese or other embodiments to assist in visualization of the intestinalwatt. The illumination channel and light may be covered by the baseportion 66 of the balloon in its partially or fully inflated state, suchthat the light is directed through the base portion and the distal dome64 to illuminate the intestinal wall. In FIGS. 23A-C, the operativechannel 102 is positioned around the longitudinal center of theendoscope 100. However, other embodiments may include an operativechannel that is off center as shown in FIG. 22.

As seen in FIGS. 23A-C, the proximal collar 63 may take differentshapes. For example, balloon 60 d of FIG. 23A may have a collar with ashaped portion that is pyramidal or tapered. Balloon 60 e of FIG. 23Bmay also have a collar with a shaped portion that is pyramidal ortapered in the opposite direction as the taper of balloon 60 d. Balloon60 f of FIG. 23C may have a collar with a shaped portion that isbulbous. In some embodiments, the shaped portion is part of the proximalelongated projecting portion 68 of the proximal collar 63. For example,FIG. 23A shows a proximal collar 63 with a proximal projecting portion68 that projects into the operative channel 102 of the endoscope. Inthis embodiment, the shaped portion is tapered and located on theproximal projecting portion 68. The wider end of the taper is positionedadjacent the base portion 66 of the proximal collar 63. Alternatively,the narrower end of the taper may be positioned adjacent the baseportion 66 as shown in FIG. 23B. In other embodiments, such as the oneshown in FIG. 23C, the shaped portion may be bulbous. The bulbous shapedportion may be spaced from the base portion 66, as shown, or it may bepositioned adjacent the base portion. FIG. 24 is a perspective view of aballoon with a tapered proximal projecting portion, similar to theembodiment of FIG. 23B. FIG. 25A is a side view of a balloon similar toFIG. 239. In 25A, section lines are drawn along the proximal projectingportion 68. These section lines indicate the transverse cross-sectionalviews shown in FIGS. 25B-D.

FIG. 26 shows an embodiment of a balloon 60 g configured for use with orwithout the cap 40. This embodiment includes a tapering shaped portion,similar to the embodiment of FIG. 24, as well as a longitudinal groove71 on the proximal collar 63. The embodiment show has one groove, butembodiments may have multiple grooves. For example, some embodiments mayhave 2, 3, 4, 5, 6, 7, 8, 9, or 10 grooves. The grooves 71 may extendonly along the proximal projecting portion 68, or may start on theproximal projecting portion and continue along the base portion 66. Thegrooves may take various shapes when viewed in transverse cross-section.For example, the grooves 71 may be any polygonal shape, or the shape ofa segment or sector of a circle or ellipse. For example, the grooves maybe hemi-spherical or trapezoidal in shape. Alternatively, the grooveswhen viewed in transverse cross-section may have multiple portions, andeach portion may take the shape of a polygon or a segment or sector of acircle or ellipse. In some embodiments, grooves 71 allow the user toeject fluid around the projecting portion 68 of the proximal collar 63for assistance in cleaning the lens 105 while projecting portion 68 isinflated and abutting the walls of the operative channel 102.Alternatively, the grooves 71 may be used to activate a suction betweenthe operative channel 102 of the endoscope and the intestinalenvironment.

FIG. 27 shows an embodiment of a balloon 60 h configured for use with orwithout the cap 40. This embodiment includes a tapering shaped portion,similar to the embodiment of FIG. 24, and also includes longitudinalgrooves 71 and trusses 73. The balloon may have multiple trusses, forexample 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,20 or more trusses. The trusses 73 may be of any shape. For example, thetrusses 73 may be cylindrical, ellipsoidal, or polygonal in shape. Thetrusses may extend from at least one proximal point to at least onedistal point on the proximal collar 63. For example, trusses 73 mayextend along only the proximal projecting portion 68, only along thebase portion 66, or along both portions 66 and 68 of collar 63. Thetrusses may act as architectural reinforcements to stabilize theballoon, keeping it in contact with the distal face of the endoscope 104and the lens 105.

The inclusion of grooves 71 or trusses 73 may give part of the proximalcollar 63 a sun beams-shaped pattern when viewed in transversecross-section (perpendicular to the longitudinal axis of the balloon).The rays of the sun beams shape are areas that thicken the wall of theballoon, such as the trusses 73 of the embodiment in FIG. 27. The sunbeams-shaped pattern includes indentations between the rays. In someembodiments, these indentations may be grooves 71, or spaces betweentrusses 73. The indentations may be configured to engage at least oneprotrusion on an underlying surface, such as the distal face 104 oroperative channel 102 of the endoscope 100. In some embodiments, theprotrusion is the lens 105. The user may position the balloon tooptimize visualization after inflation, for example by rotating theballoon such that an indentation mates with the lens 105. This allowsthe lens to image through a thinner area of the balloon wall, improvingvisualization of the intestinal structures.

FIGS. 28-33 depict attachable structures 40 d-f for coupling to anendoscope. The attachable structures may optionally be used inconjunction with balloons, as seen in FIGS. 30A-B and 31A-B. Theattachable structures may be attached at the distal end of an endoscopeand used to contact the inflated balloon for the same reasons asdescribed for seal caps 40 and 40 a-c.

Endoscopes equipped with attachable structures may also be used withoutthe balloons of the balloon access device. The attachable structures 40d-f have flexible appendages 47 d-f that reduce looping of theintestine, especially in a non-insufflated intestine. When thepractitioner pulls the endoscope back toward the opening of the bodilycavity, the attachable structures 40 d-f move the intestinal wallrelative to the imaging system, forming pleats. This movement reduceslooping, improves efficiency, and results in a less painful endoscopicprocedure for the patient. The attachable structures 40 d-f may bepositioned at the distal end of the endoscope or anywhere along theendoscope shaft.

As shown in FIGS. 28-33, the attachable structures 40 have a body 43with an outer surface 74 and an inner surface 76 which defines apassageway for passage of an endoscope. The passageway has a proximalopening 57, a distal opening 59, and a central longitudinal axis A-Aextending through the passage.

The attachable structures may take various forms, and the various formsmay be used in combination with each other. For example, some attachablestructures may be caps configured to be coupled to the distal end of theendoscope, such as the seal caps 40 and 40 a-c described in FIGS. 7-12.In FIGS. 31A-B, the balloon 60 is coupled to the distal end of theendoscope with a seal cap 40 (not visible from this angle).

Other attachable structure embodiments may be positioned along the shaftof the endoscope, such as attachable structures 40 e shown in FIGS.31A-B. In some embodiments, the attachable structure is tubular innature and configured to extend 360 degrees around the shaft of theendoscope, as seen in FIGS. 31A-B. For example, the opening of theattachable structure may be a lumen. The attachable structure may alsobe flexible and configured to be stretched around the endoscope shaft.

Certain embodiments of attachable structures may extend around only aportion of the endoscope shaft, such as 90-360 degrees around the shaft.For example, the attachable structure may be a clip configured to beattached to the endoscope shaft, and extending partially or almostcompletely around the endoscope shaft. The clip may include a fasteningmechanism, such as a hinge.

The attachable structures 40 d-f may be positionable or movable alongthe endoscope shaft. For example, the body of one or more attachablestructures may be slid, clipped, or rolled along the shaft of theendoscope as in FIG. 31A-B. Attachable structure 40 e is shown in FIGS.31A-B as an example, but other embodiments of attachable structures mayalso be movable along the endoscope shaft.

The attachable structures 40 d-f may be separated along the endoscopeshaft, as in FIG. 31A. In some embodiments, the attachable structuresare spaced from each other a distance of 5, 10, 20, 30, 40, 50, 60, or70 centimeters, or any distance between 5-70 centimeters. In otherembodiments, such as the one shown in FIG. 31B, two or more attachablestructures may be positioned adjacent another attachable structure, forexample, with a spacing of 0-2 centimeters. This closer spacing formsone or more groupings of attachable structures. For example, in FIG.31B, two groupings of 3 attachable structures 40 e are shown positionedat different points along the endoscope shaft. In some embodiments, allof the attachable structures positioned along the endoscope shaft may bepositioned adjacent each other, for example, with a spacing of 0-2centimeters.

In the embodiment shown in FIG. 32, attachable structures 40 e areattached to the outside of an elongate sheath 53. The sheath 53 isconfigured to fit tightly around the shaft of the endoscope 100. In someembodiments, the sheath 53 is a fabric or a mesh-like material as seenin FIG. 32. Attachable structures, such as 40 d-f shown in FIG. 29A-C,may be affixed to the sheath 53 by a variety of fastening means. Thesefastening means include but are not limited to glue, bonding, sutures,stitches, or hook and loop fasteners. Alternatively, an attachablestructure may take the form of an elongate sheath with multiple rows offlexible appendages.

FIG. 28A shows an exemplary attachable structure 40 d having a body 43 dwith a proximal opening 57 d, a distal opening 59 d, and a longitudinalaxis A-A extending between the openings. The length of the attachablestructure may be between 1-20 millimeters (as measured parallel to alongitudinal axis running from the proximal to the distal end). Theopening may have a radius of 2-8 mm, or an area of 12-201 mm². The areaof the opening may change at varying points between the proximal anddistal ends, or it may stay constant.

As shown in FIGS. 33A-C, the attachable structures also have a width wmeasured perpendicular to the longitudinal axis. The greatest width ofthe attachable structure extends from the tip of a first flexibleappendage 55 to the tip 55 of an appendage on the opposite side of thecentral longitudinal axis. The width w, of the attachable structure maybe 33 millimeters or less. The width w is substantially great enough toensure contact with the walls of a non-insufflated intestine.

The exemplary attachable structures 40 d-f shown in FIGS. 28-32 alsoinclude one or more flexible appendages 47 d-f extending outwardly fromthe outer surface of the body 43 d-f. As shown in FIG. 33A, the flexibleappendages 47 e may be biased toward the proximal opening 57 e of thebody, forming an acute angle, a, relative to the central longitudinalaxis. For example, the flexible appendage may extend toward the proximalopening of the attachable structure at an angle a of up to 50 degreesrelative to the central longitudinal axis. In one embodiment, theflexible appendage is biased toward the proximal opening at an angle aof 35 degrees. The bias may be manufactured during fabrication, notrequiring compression within an intestine to achieve the acute angle.

As shown in FIG. 339, the exemplary flexible appendages 47 e are alsoconfigured to bend when retracted within an intestine, such that theirtips 55 e are pointing in a direction away from the proximal opening 57e of the body. the flexible appendages 47 in their bent position form asecond acute angle a* relative to the longitudinal axis AA of the body.When the flexible appendages are in their bent position, the width w*may be 33 millimeters or less. The lack of insufflation enables closecontact between the appendages and the intestinal walls. When thesurgeon pulls back on the endoscope, the intestine is pleated by theincreased drag caused by the flexible appendages.

In some embodiments, the body and the flexible appendage of theattachable structure are made of the same material. For example, thebody and the flexible appendages may be one continuous piece ofmaterial. In other embodiments, the materials may be different and maynot be one continuous piece of material. In some embodiments, the bodymay be relatively less flexible than the at least one flexibleappendage. The attachable structures may be formed of a thermoplasticelastomer, or, in some embodiments, silicone.

As shown in FIGS. 31A-B, the exemplary flexible appendages 47 e may bealigned to each other with respect to their position along the length ofthe attachable structure 40 e, forming a row. As shown in FIG. 28B, someattachable structure embodiments may include multiple rows of flexibleappendages. For example, in FIG. 28B, the flexible appendage 47 dbelongs to a first row, and flexible appendages 49 d and 51 d belong toa second and third row of flexible appendages.

The attachable structures may comprise one or more flexible appendageswithin the same row along the length of the attachable structure. Forexample, FIGS. 29A-C show three embodiments of attachable structures, 40d, 40 e, and 40 f. Some embodiments, such as 40 d, may have just oneflexible appendage 47 d in one of the rows. That one appendage encirclesthe entire body 43 d of the attachable structure. Alternatively, theremay be multiple flexible appendages extending outward from theattachable structure within the same row. For example, in FIG. 28B, sixflexible appendages 47 e extend outward from the attachable structure 40e. In FIG. 29C, ten flexible appendages 47 f extend outward from theattachable structure 40 f. Some embodiments may comprise as many as 20flexible appendages per row, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 appendages per row of flexibleappendages. Other embodiments may have more than 20 flexible appendagesper row. The number of flexible appendages may vary depending on theposition of the row along the length of the attachable structure.

The flexible appendages may have a length of 1-5 millimeters extendingfrom an outer surface of the attachable structure. In some embodimentsof attachable structures, such as the one seen in FIG. 28B, the lengthof a flexible appendage 47 d of a first row may be shorter than thelengths of the flexible appendages 49 d and 51 d of rows that areproximally spaced from the first row along the length of the attachablestructure.

Flexible appendages 47 include base portions adjacent the body of theattachable structure and outer portions spaced outwardly from the baseportion of the appendage. The outer portions culminate in appendage tips55 as shown in FIGS. 33A-C. In some embodiments, the appendages arerelatively flat. In the relatively flat embodiments, top and bottomfaces may extend between the base portion and outer portion. The topface in these embodiments is oriented toward the distal opening of thebody, and the bottom face is oriented toward the proximal opening.

In some embodiments, the flexible appendages may be fan shaped whenviewed from the top as seen in FIG. 33C. In these embodiments, the widthacross the top face is narrower at the base portion of the appendagethan the outer portion of the appendage. In some embodiments, theflexible appendages are relatively thin. For example, the width acrossthe top face may be at least twice the distance as a thickness measuredperpendicular to the top face. Exemplary flexible appendages may have athickness between 0.1-0.9 millimeters, as measured perpendicularly fromthe top face of the appendage.

FIGS. 31A-B and FIG. 32 show embodiments where multiple attachablestructures are positioned along the shaft of an endoscope. In theseembodiments, the length of flexible appendages 47 of a distally spacedattachable structure 40 may be shorter than the lengths of flexibleappendages of proximally spaced attachable structures. For example, thelength of a flexible appendage may be 0.1-1 mm shorter than the flexibleappendage of a proximally spaced attachable structure. In embodimentswith groupings of attachable structures, such as the one shown in FIG.31B, flexible appendages of the attachable structures of a distalgrouping may be shorter than those of a proximally spaced grouping.

The endoscope equipped with attachable structures 40 d-f may be used inmethods of visualizing the internal surface of an intestinal cavity. Aspart of these methods, a practitioner attaches one or more attachablestructures to an endoscope such that the attachable structure extends atleast partially around the shaft of the endoscope as seen in FIGS.31A-B. The exemplary attachable structures may be positioned at thedistal end of the endoscope, such as attachable structure 40 in FIGS.31A-B. The exemplary attachable structures may also be positioned alongthe endoscope shaft, such as attachable structures 40 e in FIGS. 31A-B.After attachment, the flexible appendages 47 e of the attachablestructures face outwardly.

As another part of these methods, the practitioner positions theendoscope equipped with attachable structures within an intestinalcavity of a subject, such that the one or more flexible appendages 47contacts the intestinal wall. The practitioner pushes on the shaft ofthe endoscope to cause a forward advance of the endoscope. As theendoscope is pushed further into the intestinal cavity, the flexibleappendages are oriented toward the proximal end of the structure in arelatively low resistance position, as seen in FIGS. 30A and 33A.

The attachable structures 40 d-f facilitate a forward advance of theendoscope by reducing intestinal looping. When the practitioner pullsback on the shaft of the endoscope, the flexible appendages 47 flipdirections toward the distal opening of the attachable structure, asseen in FIGS. 30B and 33B. This is the relatively high resistanceposition of the flexible appendages. Pulling back on the shaft of theendoscope when the flexible appendage is in the high resistance positioncauses dragging of the intestinal wall 200, as seen in FIGS. 30A-B. Thisdragging changes the position of the intestine relative to the anus, andmay create a pleated formation and reduce looping. The reduction inlooping facilitates a forward advance of the endoscope. Upon the forwardadvance, the flexible appendage 47 flips back to its low resistanceposition.

The methods disclosed herein may be performed without insufflation ofthe intestinal cavity. The lack of insufflation promotes contact betweenthe flexible appendages of the attachable structures and the intestinalwall 200, as seen in FIGS. 30A-B.

Attachable structures 40 d-f may be attached to the endoscope in avariety of ways. In some embodiments, the practitioner may stretch theattachable structures around the distal end and the shaft of theendoscope. For example, when the attachable structure has a flexible,tubular body 43, it may be stretched around the distal end of theendoscope. The attachable structures may be positioned at the distal endof the endoscope, along the shaft, or both. If the attachable structureis a tubular, flexible embodiment, the practitioner may position it byrolling or sliding it proximally along the shaft, as seen in FIGS.31A-B. Alternatively, the attachable structures may be clipped onto theshaft. In other embodiments, the attachable structures may be positionedalong the shaft using sheath 53 shown seen in FIG. 32. For methods usingthis or similar embodiments, positioning one or more attachablestructures along the shaft includes pulling the sheath 53 over thedistal face of the endoscope.

The methods of visualizing the intestinal wall may also include balloon60, as shown in FIGS. 31A-B. In embodiments of these methods, anattachable structure 40 adjacent the distal end of the endoscope is acap configured to encircle the distal end of the endoscope. The capcontacts and secures the balloon when it is in its inflated state atover the imaging components of the endoscope. Activation of the imagingsystem causes light to be transmitted through the proximal and distalends of balloon 60.

Although the invention has been shown and described with respect to acertain embodiment or embodiments, it is obvious that equivalentalterations and modifications will occur to others skilled in the artupon the reading and understanding of this specification and the annexeddrawings. In particular regard to the various functions performed by theabove described elements (components, assemblies, devices, compositions,etc.), the terms (including a reference to a “means”) used to describesuch elements are intended to correspond, unless otherwise indicated, toany element which performs the specified function of the describedelement (i.e., that is functionally equivalent), even though notstructurally equivalent to the disclosed structure which performs thefunction in the herein illustrated exemplary embodiment or embodimentsof the invention. In addition, while a particular feature of theinvention may have been described above with respect to only one or moreof several illustrated embodiments, such feature may be combined withone or more other features of the other embodiments, as may be desiredand advantageous for any given or particular application.

What is claimed is:
 1. A method of visualizing an internal surface of anintestinal cavity using an endoscope, the method comprising; a)providing two or more attachable structures configured to attach to anddetach from an endoscope shaft, said attachable structures eachcomprising a body having a proximal end, a distal end, an openingextending between the proximal and distal ends, and at least oneflexible appendage extending outwardly from the outer surface of theattachable structure, b) attaching the two or more attachable structuresto the endoscope such that each of the two or more attachable structuresextends at least partially around the shaft of the endoscope with the atleast one flexible appendage extending outwardly from the shaft of theendoscope, such that each of the two or more attachable structures isspaced from the other of the two or more attachable structures by adistance along the shaft of the endoscope, and such that one of the twoor more attachable structures is positioned adjacent a distal face ofthe endoscope, c) positioning the endoscope and the two or moreattachable structures within the intestinal cavity of a subject, suchthat the flexible appendage of each attachable structure contacts anintestinal wall, d) pushing on the shaft of the endoscope to cause aforward advance of a distal end of the endoscope within the intestinalcavity, and e) pulling back on the shaft of the endoscope, whereinpulling back causes the flexible appendage to move the intestinal wallrelative to a proximal opening of the intestinal cavity.
 2. The methodof claim 1, further comprising promoting contact between the flexibleappendage and the intestinal wall.
 3. The method of claim 2, whereinpromoting contact comprises performing the method without insufflationof the intestinal cavity.
 4. The method of claim 1, wherein pulling backon the shaft reduces looping of the intestine.
 5. The method of claim 1,wherein attaching the two or more attachable structures comprisesstretching each attachable structure around the shaft of the endoscope.6. The method of claim 1, wherein positioning the two or more attachablestructures along the shaft comprises rolling at least one of theattachable structures proximally along the shaft.
 7. The method of claim1, wherein positioning the two or more attachable structures along theshaft comprises clipping at least one of the attachable structures alongthe shaft.
 8. The method of claim 1, further comprising an elongatesheath configured to fit tightly around the shaft of the endoscope,wherein the two or more attachable structures are attached to theoutside of the sheath, and positioning the two or more attachablestructures along the shaft of the endoscope comprises positioning thesheath around the shaft.
 9. The method of claim 8, wherein positioningthe sheath comprises pulling the sheath over the distal face of theendoscope.
 10. The method of claim 1, wherein pulling back on the shaftof the endoscope comprises dragging the intestinal wall into a pleatedformation, wherein the pleated formation facilitates an additionalforward advance of the distal end of the endoscope.
 11. The method ofclaim 1, wherein pulling back on the shaft of the endoscope causes theflexible appendage to flip directions.
 12. The method of claim 1,further comprising pushing the endoscope forward after pulling back onthe shaft of the endoscope.
 13. The method of claim 12, wherein theforward movement causes the flexible appendage to flip directions. 14.The method of claim 13, further comprising pushing the endoscope forwardbeyond the pleated formation, wherein the forward movement causes theflexible appendage to flip directions.
 15. The method of claim 1,further comprising activating an endoscope imaging system to providevisual images of the intestinal wall to a user.
 16. The method of claim1, further comprising providing a balloon configured to inflate adjacentthe distal end of the endoscope and positioning the balloon over animaging component of the endoscope.
 17. The method of claim 16, furthercomprising activating an endoscope imaging system to provide visualimages of the intestinal wall to a user, wherein activating theendoscope imaging system causes the imaging component to receive lighttransmitted through distal and proximal ends of the balloon.
 18. Themethod of claim 16, wherein one of the two or more attachable structuresis a cap configured to encircle the distal end of the endoscope, andpositioning the balloon over the imaging component of the endoscopecomprises making contact between the cap and the balloon.